Background:
To understand the relevant legislations
governing the sale of optical lens i.e. contact lens in India and further the
regulations if any on the sale of contact lens via the e-commerce platform.
Whilst I have not come across a specific
legislation regulating such sale, I would like to draw attention to the Drugs
and Cosmetics Act, 1940 (“Act”) and
the Drugs and Cosmetics Rules, 1945 (“Rules”)
made thereunder. The Act defines a drug in such a manner that it includes devices
intended for external use in the diagnosis, treatment, mitigation
or prevention of disease or disorder in human beings[1].
Contact lens are intended to correct or improve the vision of people with myopia,
hyperopia, presbyopia, and astigmatism by wearing it over the eye, thereby it
can be inferred that contact lens is in fact a device intended for external use
to treat a disorder in humans.
Chapter IV of the Act provides for the
procedure to manufacture, sell and distribute drugs, pursuant to which no drug
can be sold or manufactured or distributed which is not of a standard quality or
is misbranded, adulterated or spurious. Further Section 18 of the Act
mandatorily requires a license for the distribution or sale of drugs.
Pursuant to Rule 59, an application is required
to be made for the grant of a licence to sell, stock, exhibit or offer
for sale or distribute drugs. Accordingly duly filled Form 19/ 19A
accompanied by a fee of rupees one thousand and five hundred, if the drugs
falls under Schedule C or Schedule C1 will be made. Schedule C provides for Biological
and Special Products, and lists Ophthalmic preparations. Ophthalmic
preparations are sterile, liquid, semi-solid, or solid preparations[2]
and most commonly are eye drops and ointments. It does not seem to include
contact lens but rather the solutions and ointments required for contact lens
care and upkeep. Therefore
if the website intends to sell products such as lens solution or ointments it
will require a license for the same as such products are Ophthalmic
preparations.
As
contact lens do not fall within the Schedule C or Schedule C1, Rule 61
specifies that a license shall be issued
in Form 20, Form 20-A or Form 20-B, as the case may be to sell, stock, exhibit or offer for sale or distribute drugs. As a result a
license will be required for sale of contact lens.
Further, as the sale of contact lens
does not require a qualified person, a restricted license will be applied for
in Form 20A. In addition the conditions for sale, as per Rule 65 is as follows:
·
The
supply, otherwise than by way of wholesale dealing of any drug supplied
on the prescription of a Registered Medical Practitioner shall be
effected only by or under the personal supervision of a registered Pharmacist;
·
The
supply of any drug on a prescription of a registered medical
practitioner shall be recorded at the time of supply in a prescription
register specially maintained for the purpose and the serial number of entry in
this regard shall be entered on the prescription;
·
The
description "Drug store" shall be displayed by such licensees who do
not require the services of a registered Pharmacist[3];
Reference
the query on whether contact lens require prescriptions to be sold, please note
that Schedule H of the Rules provides the list of prescription drugs, and the
note to the schedule states that the preparations containing the substances
listed excluding those intended for topical/or external use are also
covered by this Schedule. Therefore it is clear that contact lens would not
require a prescription.
Further Schedule H1 provides that preparations
containing the drug substances and their salts as listed in Schedule H1
excluding those intended for topical or external use except ophthalmic containing
the listed substances are covered by the Schedule. To reiterate if the website
intend to sell Ophthalmic preparations it will be under a prescription if such Ophthalmic
preparations contain the substances listed in Schedule H1.
The Rules provide that the labeling[4]
and standards[5] of
Medical Devices must conform to the specifications as prescribed by the Bureau
of Indian Standards[6]. Schedule
R1 provides that medical devices as listed shall conform to the Indian
Standards specification laid down from the time to time by the Bureau of Indian
Standards, and there is no mention of Opthalmic lens/ contact lens therein. Therefore
contact lens only have to conform with the labeling requirements of BIS.
It is clear that the Act and Rules
regulate the import, manufacture, sale and distribution of Medical Devices,
however only notified medical devices are regulated in India. As per the list
of notified Medical Devices as available on the website[7]
of Central Drugs Standard Control Organization (CDSCO), there is no
notification for contact lens, however Intra Ocular Lenses (“IOL’s”) have been notified as a Medical
Device. IOL’s are implanted inside the eye to replace the eye's natural lens
when it is removed during cataract surgery, and are also used for a type of
vision correction surgery called refractive lens exchange, therefore would not
include contact lens.
(i) all medicines for internal or external use of
human beings or animals and all substances intended to be used for or in the
diagnosis, treatment, mitigation or prevention of any disease or disorder in
human beings or animals, including preparations applied on human body for the
purpose of repelling insects like mosquitoes;
(ii) such substances (other than food) intended to
affect the structure or any function of the human body or intended to be used
for the destruction of vermin or insects which cause disease in human beings or
animals, as may be specified from time to time by the Central Government by
notification in the Official Gazette;
(iii) all substances intended for use as components
of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external
use in the diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals, as may be specified from time to time by
the Central Government by notification in the Official Gazette, after
consultation with the Board;
[2]Emphasis on review available at http://www.ijpsonline.com/articles/topical-ocular-drug-delivery-a-review.pdf
[4] Rule
95: Prohibition of sale or distribution unless labeled: Subject to the other
provisions of these Rules, no person shall sell or distribute any drug
(including a patent or proprietary medicine) unless it is labelled in
accordance with these Rules.
[5] Rule
125A of the Drugs and Cosmetics Rules , 1945
[7]
Official website of CDSCO; http://www.cdsco.nic.in/writereaddata/list-of-notified-medical-device(1).pdf;
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